Certain disease states require treatment using one or more different medicaments. Some drug compounds need to be delivered in a specific relationship with each other in order to deliver the optimum therapeutic dose. The presently proposed assemblies, devices, and methods are of particular benefit where combination therapy is desirable, but not possible in a single formulation for reasons such as, but not limited to, stability, compromised therapeutic performance and toxicology.
For example, in some cases it might be beneficial to treat a diabetic with a long-acting insulin and with a glucagon-like peptide-1 (GLP-1), which is derived from the transcription product of the proglucagon gene. GLP-1 is found in the body and is secreted by the intestinal L cell as a gut hormone. GLP-1 possesses several physiological properties that make it (and its analogs) a subject of intensive investigation as a potential treatment of diabetes mellitus.
There are a number of potential problems when delivering two active medicaments or “agents” simultaneously. The two active agents may interact with each other during the long-term, shelf life storage of the formulation. Therefore, it may be advantageous to store the active components separately and combine them at the point of delivery, e.g. injection, needle-less injection, pumps, or inhalation. However, the process for combining the two agents needs to be simple and convenient for the user to perform reliably, repeatedly and safely.
A further potential problem is that the quantities and/or proportions of each active agent making up the combination therapy may need to be varied for each user or at different stages of his therapy. For example, one or more active agents may require a titration period to gradually introduce a patient up to a “maintenance” dose. A further example would be if one active agent requires a non-adjustable fixed dose while the other is varied in response to a patient's symptoms or physical condition. This potential problem means that pre-mixed formulations of multiple active agents may not be suitable as these pre-mixed formulations would have a fixed ratio of the active components, which could not be varied by the healthcare professional or user.
Additional problems can arise where a multi-drug compound therapy is required, because certain users may not be able to cope with having to use more that one drug delivery system or to make the necessary accurate calculation of the required dose combination. This is especially true for users with dexterity or computational difficulties.
Accordingly, there exists a need to provide assemblies, devices, and methods for the delivery of two or more medicaments in a single injection or delivery step that is simple for the user to perform. The presently proposed assemblies, devices, and methods overcome the above-mentioned problems by providing separate storage containers or reservoirs for two or more active drug agents (e.g. a first or primary medicament and a second or secondary medicament).
Specifically, a needle assembly is attachable to a drug delivery device containing a first medicament. The needle assembly may comprise a main body and a septum positioned within a cavity defined in part by the main body. A stopper may be positioned within the cavity such that the main body cavity, the septum, and the stopper define a reservoir. A needle having a proximal end may be positioned in the stopper and a release mechanism may be positioned near a distal end of the main body. A biasing element may be positioned to drive the stopper such that, during a dose dispensing step of the drug delivery device, the release mechanism may be activated to drive the proximal end of the needle out of the septum so that the proximal end of the needle resides in the reservoir. The biasing element may also drive the stopper proximally. A second medicament may be provided in the reservoir of the needle assembly. In addition, this reservoir of the needle assembly may be filled with the second medicament by way of a sealable opening. This sealable opening may be provided on the main body.
The proposed assemblies, devices, and methods may also give the opportunity for varying the quantity of one or both the first and second medicaments. For example, one fluid quantity can be varied by changing the properties of the needle assemblies and/or injection device (e.g. dialing a user variable dose and/or changing the device's “fixed” dose). The second fluid quantity can be changed by manufacturing a variety of secondary drug containing packages with each variant comprising a reservoir containing a different volume and/or concentration of the second active agent. The user or healthcare professional would then be able to select the most appropriate secondary package or series or combination of series of different packages for a particular treatment regime. In an other example, the quantity of the second medicament delivered during dispense may be varied by varying the user variable dose of the first medicament.
These and other advantages will become evident from the following more detailed description of the invention.
One of the problems to be solved by the present invention is to provide a needle assembly and a method where the safety and the comfort of the user is increased.